MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-32-320

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical notification received for left hip revision to address multiple subluxations.Date of implantation: (b)(6) 2019.Date of revision: (b)(6) 2020; (left hip).Treatment: head and liner revised.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: b1.

Manufacturer Narrative

Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Event Description

Additional information received for medical records: doi: on (b)(6) 2019.Patient received a left primary tha to treat end-stage arthrosis.Tha components implanted included a pinnacle cup utilizing an unknown hole cover, a pinnacle altrx polyethylene liner, depuy cocr femoral head, and a cemented summit femoral stem.The manufacturer of the cement and cement restrictor is unknown.The procedure was completed without complications.Clinic note dated on (b)(6) 2020.Patient presented 6 weeks status post tha with pain.Patient reports a subluxation after placing left foot on a chair and bending to pick up a shampoo bottle.Surgeon notes there was no frank dislocation and patient was advised to postoperative dislocation precautions.Clinic note dated on (b)(6) 2020.Patient presents with left hip pain and tenderness and reports feelings of left hip popping with abduction.X-rays were unremarkable.Patient is placed in an abduction brace.Clinic note dated on (b)(6) 2020.Patient presents with pain and tenderness following a dislocation of the left hip.Dislocation was reduced in the er.X-rays were unremarkable.Surgeon determines the patient has torn her left capsular repair and is unstable.The patient is referred for revision.Dor: on (b)(6) 2020: patient received a revision of the liner and head to treat recurrent instability and dislocations.The stem and cup were well-fixed and retained.The pseudocapsule was repaired.The patient was revised with depuy products.The procedure was completed without complications.

Manufacturer Narrative

Product complaint # (b)(4).No code available ((b)(4)) used to capture the limb asymmetry.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.

Event Description

In addition to the previously indicated issues prior to revision on (b)(6) 2020, the patient was also experiencing limb asymmetry.

• Brand Name: DELTA CER HEAD 12/14 32MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9962761
• MDR Text Key: 187854468
• Report Number: 1818910-2020-10789
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• Combination Product (y/n): N
• PMA/PMN Number: K031803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1365-32-320
• Device Catalogue Number: 136532320
• Device Lot Number: 9269760
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 32IDX50OD; PINNACLE SECTOR II CUP 50MM; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 68